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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC ESPRIT VENTILATOR
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RESPIRONICS CALIFORNIA, INC ESPRIT VENTILATOR Back to Search Results
Model Number V1000
Device Problem Defective Alarm (1014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2019.Date of report: 05/31/2019.A follow-up report will be submitted once the investigation has been complete.
 
Event Description
The customer reported that the o2 alarm would not turn off.No patient or user harm was reported.
 
Manufacturer Narrative
Date of report : 22jul2019, date rec¿d by mfr : 26jun2019.The manufacturer's field service engineer could not duplicate the reported complaint.No external o2 sensor present at patient outlet, ran unit at set parameters, unit cycles normally.Noted code 5003 in log, ran unit for 20 min at 100% o2, no alarms activated, internal voltage stable at 0.57v, no evidence of o2 leak, cooling fans are operational.The manufacturer's field service engineer could not find any problem, extended system test (est) passed.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
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Brand Name
ESPRIT VENTILATOR
Type of Device
VENTILATOR
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, INC
2271 cosmos court
carlsbad CA 92011
MDR Report Key8659879
MDR Text Key147178332
Report Number2031642-2019-03380
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
PMA/PMN Number
K981072
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 05/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberV1000
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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